EP0782462B1 - Pressure-controlled breathing aid - Google Patents

Pressure-controlled breathing aid Download PDF

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Publication number
EP0782462B1
EP0782462B1 EP95930565A EP95930565A EP0782462B1 EP 0782462 B1 EP0782462 B1 EP 0782462B1 EP 95930565 A EP95930565 A EP 95930565A EP 95930565 A EP95930565 A EP 95930565A EP 0782462 B1 EP0782462 B1 EP 0782462B1
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EP
European Patent Office
Prior art keywords
volume
pressure
inspiratory
breathed
command
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Revoked
Application number
EP95930565A
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German (de)
French (fr)
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EP0782462A1 (en
Inventor
Guy Bourdon
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Mallinckrodt Developpement France SAS
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Nellcor Puritan Bennett France Developpement
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0042—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the expiratory circuit

Definitions

  • the present invention relates to an aid device pressure controlled breathing.
  • a device according to the preamble of claim 1 is known from document FR-A-2695830.
  • Respiratory devices - or devices ventilation - commonly used in ventilation mechanics can be classified into two main groups, namely volumetric devices characterized by the delivery of a specific volume at each cycle respiratory, and pressure controlled devices, characterized by the delivery of a determined pressure at each respiratory cycle.
  • Volumetric devices have the advantage of guarantee a specified respiratory rate, but they have major drawbacks. In particular, they put the patient at risk of barotrauma because they tend to apply pressure which increases in end of insufflation. In addition, the patient risks mismatch with the device in the sense that the reflexes patient's respiratory tract may appear times different from when the volumes imposed by the device finish being delivered.
  • devices controlled by pressure allow much better patient synchronization with the device and avoid the risk of barotrauma since the maximum pressure delivered is known in advance.
  • the volume delivered to patient at each cycle and the respiratory rate is not guaranteed.
  • the purpose of the present invention is to provide a breathing aid device that combines the benefits of the two known ventilation modes discussed above.
  • the aid device respiratory in known pressure mode is characterized by the characteristics of the second Part of claim 1.
  • the pressure is adjusted in a direction tending to ensure the predetermined volume applied as a setpoint.
  • we guarantee a volume without taking the may increase the pressure in a way uncontrolled, or create any particular risk of mismatch between the patient's breathing rate and that of the device.
  • the invention is perfectly compatible with devices like described in FR-A-2 695 830 in which the device detects the patient's respiratory reflexes for to pass from the inspiratory phases to the expiratory phases and vice versa.
  • the device known by EP-A-419551 differs from this device in that the pressure prevailing in the branch is by set.
  • the expression “respiratory rate” to designate also well the flow of breathing gas inspired or exhaled by unit of time, that volume or amount of gas inspired or exhaled by respiratory cycle.
  • the means of regulation apply to inspiratory pressure a variation in pressure which is equal in percentage to the difference between the flow inspiratory and instruction.
  • the respiratory aid device includes a circuit patient 1 including a patient connection 2, namely a facial or nasal mask, or a probe intubation or tracheostomy, connected to a branch inspiratory 3 and to an expiratory branch 4 by through a bidirectional branch 5.
  • the expiratory branch 4 includes a device expiration 6 which, not shown, includes an exhalation valve and control means for this valve.
  • the exhalation valve is closed.
  • the exhalation valve may be is open for the patient to exhale on pressure atmospheric, or operate like a valve discharge to force the patient to breathe out under a some predetermined overpressure.
  • the inspiratory branch 3 is connected, to its opposite end to mask 2, to a module ventilation by inspiratory aid 8 which includes means, such as a speed motor-turbine group adjustable, to deliver breathable gas through the inspiratory branch 3 under adjustable pressure, in direction of mask 2, means for detecting patient's respiratory reflexes, for example from variations in instantaneous flow, and means for order the expiration valve of the exhalation means 6 and an inspiration valve placed on the branch inspiratory 3 to open the inspiration valve and close the exhalation valve during the phases and close the inspiration valve and release the exhalation valve during the phases expiratory.
  • the patient communicates tightly with the branch inspiratory 3 and the volume circulating in the branch inspiratory 3 corresponds to the volume of gas inspired.
  • the patient communicates tightly with the expiratory branch 4 and the volume circulating in the expiratory branch 4 corresponds to the volume of exhaled gas.
  • the ventilation module 8 may include means pressure control by which the pressure P detected in inspiratory branch 3 by a detector 10 is compared with a pressure setpoint AI for set for example the rotation speed of the group mototurbine in the direction tending to make the pressure P equal to the AI setpoint.
  • the aid device respiratory comprises means 11 for regulating the patient's respiratory rate.
  • the means of regulation 11 include a module 9 for controlling the setpoint of pressure AI that the ventilation module 8 must apply to inspiratory branch 3 during the phases inspirational.
  • the regulation means 11 also include a patient-inspired VTI volume measurement module 12 during each respiratory cycle.
  • Module 12 provides the control module 9 with a signal indicative of the VTI volume.
  • the control module 9 includes an input 13 to receive the VTI signal, and three inputs 14, 16, 17, allowing the user of the device to enter a flow setpoint in the control module minimum respiratory, in the form of a minimum of volume inspired by VTImini cycle, a setpoint of minimum inspiratory pressure AImini, and a setpoint of maximum inspiratory pressure AImaxi.
  • control module 9 compares the measured VTI flow with the VTImini setpoint and adjusts the pressure setpoint AI in the direction of approximate the measured flow rate VTI to the setpoint VTImini, without, however, removing the AI setpoint from the interval between the two extremes AImini and AImaxi. In this interval, the control module 9 tends to increase the AI setpoint when the volume VTI measured is lower than the VTImini setpoint, and reduce the AI pressure setpoint in the case opposite.
  • VTImini and AImini setpoints such as flow respiratory VTI is established at a value greater than VTImini when the AI pressure setpoint is equal AImini. So if the patient breathes as expected, the pressure setpoint AI stabilizes at AImini with a respiratory rate above minimum setpoint VTImini. Only in the event of an anomaly or incident respiratory, for example partial obstruction of respiratory tract, that the measured respiratory flow VTI is likely to become lower than VTImini, thus causing an increase in the AI setpoint established by the control module 9. When the breathing returns to normal, respiratory rate again becomes greater than the VTImini setpoint, so that the control module 9 returns more or less quickly the AI pressure setpoint at the AImini value.
  • AI is made equal to AImini (step 18).
  • the VTI measurement of the volume inspired during the previous inspiratory phase is acquired (step 19) then compared to the setpoint VTImini by test 21. If the measured volume VTI is greater than or equal to VTImini, in other words if the volume inspired by the patient is satisfactory, a test 22 determines whether the AI pressure setpoint is or not greater than the minimum AImini. If the pressure setpoint is equal to the minimum, so we are in the conditions ideal (volume at least equal to minimum, pressure minimum), and we therefore return directly to step 19 acquisition of the next inspired volume measurement.
  • test 21 if it is lower than the setpoint VTImini, we will try to increase the setpoint of AI pressure to further assist the patient. But to beforehand, by a test 24, we will check if the setpoint pressure AI does not already reach the maximum AImaxi. Yes yes, an alarm is triggered (step 26) to signal the need for urgent intervention.
  • step 23 we go as before in step 23 by which it will be applied to the setpoint AI an equal percentage change and opposite in sign to the difference between the measured VTI volume and the VTImini setpoint.
  • the AI setpoint decreased or increased as calculated in step 23, we will first check by a test 27 if the new value AI calculated does not exceed the maximum AImaxi, and by a test 28 that it is not less than the minimum AImini.
  • the AI setpoint which will be applied to the ventilation module 8 will be equal to the extremum in question (steps 29 and 31).
  • the respiratory rate is no longer measured through the volume inspired at each cycle but through the expired VTE volume on each cycle.
  • the minimum respiratory rate setpoint applied to the control module 9 is then a VTEmini setpoint volume expired per cycle, so that it can be directly compared to the measurement provided by the module 32.
  • the measurement module 42 is this time installed in the bidirectional branch 5 of the patient circuit 1 and it comprises means 43 for selecting the direction of the flow whose volume is to be measured. Depending of this selection, the module 42 provides a choice of measurement of VTI or VTE. Depending on the mode of operation of the measurement module 42, the measurement module command 9 interprets as a volume setpoint inspired or as an expired volume setpoint the input applied in 14. There is no longer a measurement module on the inspiratory branch 3 nor on the expiratory branch 4.
  • the speed of execution of the flowchart of figure 2 is sufficient for the volume measurement to each respiratory cycle corrects the pressure applied during the inspiratory phase next.
  • the pressure correction intervenes only during the course, and not from the start, of the next inspiratory phase.
  • the invention is applicable to all fans capable of measuring the volumes or flows delivered and automatically control the pressure value insufflation.
  • the invention is applicable to all modes of ventilation by pressure control, and in particular in the "inspiratory aid" and “controlled pressure” modes.
  • Inspiratory support is a mode of maintaining during insufflation a pressure appreciably constant in the patient circuit, the patient triggering the start and end of insufflation by its respiratory reflexes.
  • the pressure controlled mode is identical to the inspiratory aid mode, except that the patient does not trigger the end of insufflation, this being determined by a fixed time.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Description

La présente invention concerne un dispositif d'aide respiratoire commandé en pression. Un dispositif selon le préambule de la revendication 1 est connu par le document FR-A-2695830.The present invention relates to an aid device pressure controlled breathing. A device according to the preamble of claim 1 is known from document FR-A-2695830.

Les dispositifs d'aide respiratoire - ou dispositifs de ventilation - utilisés couramment dans la ventilation mécanique peuvent se classer en deux groupes principaux, à savoir les appareils volumétriques caractérisés par la délivrance d'un volume déterminé à chaque cycle respiratoire, et les appareils commandés en pression, caractérisés par la délivrance d'une pression déterminée à chaque cycle respiratoire.Respiratory devices - or devices ventilation - commonly used in ventilation mechanics can be classified into two main groups, namely volumetric devices characterized by the delivery of a specific volume at each cycle respiratory, and pressure controlled devices, characterized by the delivery of a determined pressure at each respiratory cycle.

Les appareils volumétriques ont l'avantage de garantir un débit respiratoire déterminé, mais ils présentent des inconvénients majeurs. En particulier, ils exposent le patient à des risques de barotraumatisme car ils tendent à appliquer une pression qui croít en fin d'insufflation. En outre, le patient risque de se désadapter à l'appareil en ce sens que les réflexes respiratoires du patient peuvent apparaítre à des moments différents de ceux où les volumes imposes par l'appareil finissent d'être délivrés.Volumetric devices have the advantage of guarantee a specified respiratory rate, but they have major drawbacks. In particular, they put the patient at risk of barotrauma because they tend to apply pressure which increases in end of insufflation. In addition, the patient risks mismatch with the device in the sense that the reflexes patient's respiratory tract may appear times different from when the volumes imposed by the device finish being delivered.

Au contraire, les appareils commandés en pression permettent une bien meilleure synchronisation du patient avec l'appareil et d'éviter les risques de barotraumatisme puisque la pression maximum délivrée est connue à l'avance. Par contre, le volume délivré au patient à chaque cycle et le débit respiratoire ne sont pas garantis.On the contrary, devices controlled by pressure allow much better patient synchronization with the device and avoid the risk of barotrauma since the maximum pressure delivered is known in advance. However, the volume delivered to patient at each cycle and the respiratory rate is not guaranteed.

Le but de la présente invention est de proposer un dispositif d'aide respiratoire qui combine les avantages des deux modes de ventilation connus discutés plus haut.The purpose of the present invention is to provide a breathing aid device that combines the benefits of the two known ventilation modes discussed above.

Suivant l'invention, le dispositif d'aide respiratoire en mode pression connu, est caractérisé par les caractéristiques de la seconde partie de la revendication 1.According to the invention, the aid device respiratory in known pressure mode, is characterized by the characteristics of the second Part of claim 1.

Ainsi, on règle la pression dans un sens tendant à assurer le volume prédéterminé appliqué comme consigne. De cette façon, on garantit un volume sans prendre le risque de faire augmenter la pression d'une manière incontrôlée, ni créer de risque particulier de désadaptation entre la cadence respiratoire du patient et celle de l'appareil. En particulier, l'invention est parfaitement compatible avec les dispositifs du genre décrits dans le FR-A-2 695 830 dans lesquels l'appareil détecte les réflexes respiratoires du patient pour passer des phases inspiratoires aux phases expiratoires et inversement. Le dispositif connu par EP-A-419551 différe de ce dispositif en ce que la pression régnant dans la branche n'est par réglée.Thus, the pressure is adjusted in a direction tending to ensure the predetermined volume applied as a setpoint. In this way, we guarantee a volume without taking the may increase the pressure in a way uncontrolled, or create any particular risk of mismatch between the patient's breathing rate and that of the device. In particular, the invention is perfectly compatible with devices like described in FR-A-2 695 830 in which the device detects the patient's respiratory reflexes for to pass from the inspiratory phases to the expiratory phases and vice versa. The device known by EP-A-419551 differs from this device in that the pressure prevailing in the branch is by set.

Pour éviter tout risque de barotraumatisme, il est avantageux de prévoir des moyens pour fixer une pression maximum prédéterminée que la pression appliquée au patient ne pourra pas dépasser même si le volume ou le débit délivré est insuffisant.To avoid any risk of barotrauma, it is advantageous to provide means for fixing a pressure predetermined maximum that the pressure applied to the patient cannot exceed even if the volume or flow delivered is insufficient.

Il est également avantageux de prévoir un dispositif de signalisation ou autre alarme détectant l'occurrence simultanée de l'insuffisance du débit et du réglage de la pression à sa valeur maximum prédéterminée, pour signaliser cette situation d'incapacité de l'appareil à assurer le débit respiratoire fixé comme consigne.It is also advantageous to provide a device signal or other alarm detecting the occurrence simultaneous insufficient flow and regulation the pressure at its predetermined maximum value, for report this situation of incapacity of the device to ensure the respiratory rate set as set.

Dans le cadre de la présente invention, on emploie l'expression "débit respiratoire" pour désigner aussi bien le débit de gaz respirable inspiré ou expiré par unité de temps, que le volume ou la quantité de gaz inspiré ou expiré par cycle respiratoire.In the context of the present invention, the expression "respiratory rate" to designate also well the flow of breathing gas inspired or exhaled by unit of time, that volume or amount of gas inspired or exhaled by respiratory cycle.

De préférence, les moyens de régulation appliquent à la pression inspiratoire une variation de pression qui est égale en pourcentage à l'écart entre le débit inspiratoire et la consigne.Preferably, the means of regulation apply to inspiratory pressure a variation in pressure which is equal in percentage to the difference between the flow inspiratory and instruction.

Toutefois, dans le cas où un extremum de pression est prévu et si l'application d'une telle variation conduirait à franchir l'extremum, la nouvelle pression inspiratoire est rendue égale à l'extremum de pression.However, in the event that a pressure extremum is expected and if the application of such variation would lead to cross the extremum, the new pressure inspiratory is made equal to the pressure extremum.

D'autres particularités et avantages de l'invention ressortiront encore de la description ci-après, relative à des exemples non limitatifs.Other features and advantages of the invention will emerge further from the description below, relating to nonlimiting examples.

Aux dessins annexés :

  • la figure 1 est un schéma d'un premier mode de réalisation du dispositif selon l'invention ;
  • la figure 2 est un organigramme de fonctionnement des moyens de régulation du dispositif de la figure 1 ; et
  • les figures 3 et 4 sont deux schémas analogues à la figure 1 mais relatifs à deux modes de réalisation du dispositif selon l'invention.
In the accompanying drawings:
  • Figure 1 is a diagram of a first embodiment of the device according to the invention;
  • Figure 2 is a flowchart of operation of the regulation means of the device of Figure 1; and
  • Figures 3 and 4 are two diagrams similar to Figure 1 but relating to two embodiments of the device according to the invention.

Dans l'exemple représenté à la figure 1, le dispositif d'aide respiratoire comprend un circuit patient 1 comprenant à son tour un raccordement patient 2, à savoir un masque facial, ou nasal, ou une sonde d'intubation ou de trachéotomie, raccordé à une branche inspiratoire 3 et à une branche expiratoire 4 par l'intermédiaire d'une branche bidirectionnelle 5. La branche expiratoire 4 comporte un dispositif d'expiration 6 qui, de manière non représentée, comporte une valve d'expiration et des moyens de commande de cette valve. Pendant les phases inspiratoires de la respiration du patient, la valve d'expiration est fermée. Pendant les phases expiratoires de la respiration du patient, la valve d'expiration peut être soit ouverte pour que le patient expire à la pression atmosphérique, soit fonctionner à la manière d'un clapet de décharge pour obliger le patient à expirer sous une certaine surpression prédéterminée.In the example shown in Figure 1, the respiratory aid device includes a circuit patient 1 including a patient connection 2, namely a facial or nasal mask, or a probe intubation or tracheostomy, connected to a branch inspiratory 3 and to an expiratory branch 4 by through a bidirectional branch 5. The expiratory branch 4 includes a device expiration 6 which, not shown, includes an exhalation valve and control means for this valve. During the inspirational phases of the patient breathing, the exhalation valve is closed. During the expiratory phases of the patient breathing, the exhalation valve may be is open for the patient to exhale on pressure atmospheric, or operate like a valve discharge to force the patient to breathe out under a some predetermined overpressure.

La branche inspiratoire 3 est reliée, à son extrémité opposée au masque 2, à un module de ventilation par aide inspiratoire 8 qui comprend des moyens, tels qu'un groupe moto-turbine à vitesse réglable, pour délivrer du gaz respirable à travers la branche inspiratoire 3 sous pression réglable, en direction du masque 2, des moyens pour détecter les réflexes respiratoires du patient, par exemple d'après les variations de débit instantané, et des moyens pour commander la valve d'expiration des moyens d'expiration 6 et une valve d'inspiration placée sur la branche inspiratoire 3 pour ouvrir la valve d'inspiration et fermer la valve d'expiration pendant les phases inspiratoires, et fermer la valve d'inspiration et libérer la valve d'expiration pendant les phases expiratoires. Ainsi, en phase inspiratoire, le patient communique de manière étanche avec la branche inspiratoire 3 et le volume circulant dans la branche inspiratoire 3 correspond au volume de gaz inspiré. Et pendant les phases expiratoires, le patient communique de manière étanche avec la branche expiratoire 4 et le volume circulant dans la branche expiratoire 4 correspond au volume de gaz expiré.The inspiratory branch 3 is connected, to its opposite end to mask 2, to a module ventilation by inspiratory aid 8 which includes means, such as a speed motor-turbine group adjustable, to deliver breathable gas through the inspiratory branch 3 under adjustable pressure, in direction of mask 2, means for detecting patient's respiratory reflexes, for example from variations in instantaneous flow, and means for order the expiration valve of the exhalation means 6 and an inspiration valve placed on the branch inspiratory 3 to open the inspiration valve and close the exhalation valve during the phases and close the inspiration valve and release the exhalation valve during the phases expiratory. So, in the inspiratory phase, the patient communicates tightly with the branch inspiratory 3 and the volume circulating in the branch inspiratory 3 corresponds to the volume of gas inspired. And during the expiratory phases, the patient communicates tightly with the expiratory branch 4 and the volume circulating in the expiratory branch 4 corresponds to the volume of exhaled gas.

De tels dispositifs d'aide inspiratoire, ou des dispositifs d'aide inspiratoire du même genre, sont décrits dans l'art antérieur en particulier dans le FR-A-2 695 830.Such inspiratory support devices, or inspiratory aids of the same kind are described in the prior art in particular in the FR-A-2 695 830.

Le module de ventilation 8 peut comporter des moyens d'asservissement en pression par lesquels la pression P détectée dans la branche inspiratoire 3 par un détecteur 10 est comparée à une consigne de pression AI pour régler par exemple la vitesse de rotation du groupe mototurbine dans le sens tendant à rendre la pression P égale à la consigne AI. The ventilation module 8 may include means pressure control by which the pressure P detected in inspiratory branch 3 by a detector 10 is compared with a pressure setpoint AI for set for example the rotation speed of the group mototurbine in the direction tending to make the pressure P equal to the AI setpoint.

Suivant l'invention, le dispositif d'aide respiratoire comprend des moyens de régulation 11 du débit respiratoire du patient. Les moyens de régulation 11 comprennent un module 9 de commande de la consigne de pression AI que le module de ventilation 8 doit appliquer à la branche inspiratoire 3 pendant les phases inspiratoires.According to the invention, the aid device respiratory comprises means 11 for regulating the patient's respiratory rate. The means of regulation 11 include a module 9 for controlling the setpoint of pressure AI that the ventilation module 8 must apply to inspiratory branch 3 during the phases inspirational.

Les moyens de régulation 11 comprennent en outre un module 12 de mesure du volume VTI inspiré par le patient au cours de chaque cycle respiratoire. Le module 12 fournit au module de commande 9 un signal indicatif du volume VTI. Le module de commande 9 comprend une entrée 13 pour recevoir le signal VTI, et trois entrées 14, 16, 17, permettant à l'utilisateur du dispositif d'entrer dans le module de commande une consigne de débit respiratoire minimum, sous la forme d'un minimum de volume inspiré par cycle VTImini, une consigne de pression inspiratoire minimum AImini, et une consigne de pression inspiratoire maximum AImaxi.The regulation means 11 also include a patient-inspired VTI volume measurement module 12 during each respiratory cycle. Module 12 provides the control module 9 with a signal indicative of the VTI volume. The control module 9 includes an input 13 to receive the VTI signal, and three inputs 14, 16, 17, allowing the user of the device to enter a flow setpoint in the control module minimum respiratory, in the form of a minimum of volume inspired by VTImini cycle, a setpoint of minimum inspiratory pressure AImini, and a setpoint of maximum inspiratory pressure AImaxi.

D'une manière générale, le module de commande 9 compare le débit mesuré VTI avec la consigne VTImini et ajuste la consigne de pression AI dans le sens tendant à rapprocher le débit mesuré VTI de la consigne VTImini, sans toutefois faire sortir la consigne AI de l'intervalle compris entre les deux extremum AImini et AImaxi. Dans cet intervalle, le module de commande 9 tend à faire augmenter la consigne AI lorsque le volume VTI mesuré est inférieur à la consigne VTImini, et à réduire la consigne de pression AI dans le cas contraire.In general, the control module 9 compares the measured VTI flow with the VTImini setpoint and adjusts the pressure setpoint AI in the direction of approximate the measured flow rate VTI to the setpoint VTImini, without, however, removing the AI setpoint from the interval between the two extremes AImini and AImaxi. In this interval, the control module 9 tends to increase the AI setpoint when the volume VTI measured is lower than the VTImini setpoint, and reduce the AI pressure setpoint in the case opposite.

A la mise en route de l'appareil, on choisit les consignes VTImini et AImini telles que le débit respiratoire VTI s'établisse à une valeur supérieure à VTImini lorsque la consigne de pression AI est égale AImini. Ainsi, si le patient respire comme prévu, la consigne de pression AI se stabilise à AImini avec un débit respiratoire supérieur à la consigne de minimum VTImini. Ce n'est qu'en cas d'anomalie ou incident respiratoire, par exemple obstruction partielle des voies respiratoires, que le débit respiratoire mesuré VTI est susceptible de devenir inférieur à VTImini, provoquant ainsi une augmentation de la consigne AI établie par le module de commande 9. Lorsque la respiration redevient normale, le débit respiratoire redevient supérieur à la consigne VTImini, de sorte que le module de commande 9 ramène plus ou moins rapidement la consigne de pression AI à la valeur AImini.When the device is started, we choose the VTImini and AImini setpoints such as flow respiratory VTI is established at a value greater than VTImini when the AI pressure setpoint is equal AImini. So if the patient breathes as expected, the pressure setpoint AI stabilizes at AImini with a respiratory rate above minimum setpoint VTImini. Only in the event of an anomaly or incident respiratory, for example partial obstruction of respiratory tract, that the measured respiratory flow VTI is likely to become lower than VTImini, thus causing an increase in the AI setpoint established by the control module 9. When the breathing returns to normal, respiratory rate again becomes greater than the VTImini setpoint, so that the control module 9 returns more or less quickly the AI pressure setpoint at the AImini value.

On va maintenant décrire plus en détail, en référence à la figure 2, l'organigramme mis en oeuvre par le module de commande 9. Au début, AI est rendu égal à AImini (étape 18).We will now describe in more detail, in reference to FIG. 2, the flow chart implemented by the control module 9. At the start, AI is made equal to AImini (step 18).

Ensuite, à la fin de chaque cycle respiratoire, ou au cours de chaque phase expiratoire, la mesure VTI du volume inspiré lors de la phase inspiratoire précédente est acquise (étape 19) puis comparée à la consigne VTImini par le test 21. Si le volume mesuré VTI est supérieur ou égal à VTImini, autrement dit si le volume inspiré par le patient est satisfaisant, un test 22 détermine si la consigne de pression AI est ou non supérieure au minimum AImini. Si la consigne de pression est égale au minimum, on est donc dans les conditions idéales (volume au moins égal au minimum, pression minimum), et on retourne donc directement à l'étape 19 d'acquisition de la mesure du volume inspiré suivant. Dans le cas contraire, on va profiter du fait que le volume inspiré est satisfaisant pour tenter de réduire la consigne de pression par une étape 23 dans laquelle on applique à la consigne de pression AI, exprimée en valeur relative, une variation égale en pourcentage et opposée en signe à l'écart entre le volume inspiré mesuré VTI et la consigne VTImini. La formule est telle que dans le cas particulier où le volume mesuré VTI est égal à VTImini, aucune modification n'est appliquée à la consigne de pression AI (variation de 0 %). Then, at the end of each respiratory cycle, or during each expiratory phase, the VTI measurement of the volume inspired during the previous inspiratory phase is acquired (step 19) then compared to the setpoint VTImini by test 21. If the measured volume VTI is greater than or equal to VTImini, in other words if the volume inspired by the patient is satisfactory, a test 22 determines whether the AI pressure setpoint is or not greater than the minimum AImini. If the pressure setpoint is equal to the minimum, so we are in the conditions ideal (volume at least equal to minimum, pressure minimum), and we therefore return directly to step 19 acquisition of the next inspired volume measurement. Otherwise, we will take advantage of the fact that the inspired volume is satisfactory in an attempt to reduce the pressure setpoint by a step 23 in which we apply to the pressure setpoint AI, expressed in relative value, an equal percentage change and opposite in sign to the gap between the inspired volume measured VTI and the VTImini setpoint. The formula is such that in the particular case where the measured volume VTI is equal to VTImini, no modification is applied to the AI pressure setpoint (0% variation).

En revenant maintenant au test 21 sur le volume mesuré VTI, si celui-ci est inférieur à la consigne VTImini, on va chercher à augmenter la consigne de pression AI pour assister davantage le patient. Mais au préalable, par un test 24, on va vérifier si la consigne de pression AI n'atteint pas déjà le maximum AImaxi. Si oui, une alarme est déclenchée (étape 26) pour signaler la nécessité d'une intervention urgente.Returning now to test 21 on volume measured VTI, if it is lower than the setpoint VTImini, we will try to increase the setpoint of AI pressure to further assist the patient. But to beforehand, by a test 24, we will check if the setpoint pressure AI does not already reach the maximum AImaxi. Yes yes, an alarm is triggered (step 26) to signal the need for urgent intervention.

Au contraire, si la consigne de pression AI n'est pas encore égale à AImaxi, on se rend comme précédemment à l'étape 23 par laquelle il va être appliqué à la consigne AI une variation égale en pourcentage et opposée en signe à l'écart entre le volume VTI mesuré et la consigne VTImini.On the contrary, if the pressure setpoint AI is not not yet equal to AImaxi, we go as before in step 23 by which it will be applied to the setpoint AI an equal percentage change and opposite in sign to the difference between the measured VTI volume and the VTImini setpoint.

Avant d'appliquer effectivement à l'entrée du module de ventilation 8, la consigne AI diminuée ou augmentée telle qu'elle a été calculée à l'étape 23, on va d'abord vérifier par un test 27 si la nouvelle valeur AI calculée ne dépasse pas le maximum AImaxi, et par un test 28 qu'elle n'est pas inférieure au minimum AImini.Before actually applying to the module entry ventilation 8, the AI setpoint decreased or increased as calculated in step 23, we will first check by a test 27 if the new value AI calculated does not exceed the maximum AImaxi, and by a test 28 that it is not less than the minimum AImini.

Si la nouvelle valeur AI franchit l'un ou l'autre de ces extremum, la consigne AI qui sera appliquée au module de ventilation 8 sera égale à l'extremum en question (étapes 29 et 31).If the new AI value exceeds either of these extremum, the AI setpoint which will be applied to the ventilation module 8 will be equal to the extremum in question (steps 29 and 31).

L'exemple de la figure 3 ne sera décrit que pour ses différences par rapport à celui de la figure 1.The example in Figure 3 will only be described for its differences from that in Figure 1.

Dans l'exemple de la figure 3, le débit respiratoire n'est plus mesuré à travers le volume inspiré à chaque cycle, mais à travers le volume VTE expiré à chaque cycle. Pour cela, on a supprimé le module de mesure de VTI 12 sur la branche inspiratoire 3, et on l'a remplacé par un module de mesure de VTE 32 sur la branche expiratoire 4.In the example in Figure 3, the respiratory rate is no longer measured through the volume inspired at each cycle but through the expired VTE volume on each cycle. For this, we removed the measurement module from VTI 12 on inspiratory branch 3, and we replaced it by a VTE 32 measurement module on the branch expiratory 4.

La consigne de débit respiratoire minimum appliquée au module de commande 9 est alors une consigne VTEmini de volume expiré par cycle, de manière à pouvoir être comparée directement à la mesure fournie par le module 32.The minimum respiratory rate setpoint applied to the control module 9 is then a VTEmini setpoint volume expired per cycle, so that it can be directly compared to the measurement provided by the module 32.

Il peut y avoir intérêt à sélectionner cas par cas la mesure sur le volume inspiré ou la mesure sur le volume expiré. C'est la solution proposée par le mode de réalisation de la figure 4, qui ne sera décrit que pour ses différences par rapport à celui de la figure 1.It may be beneficial to select case by case the measurement on the inspired volume or the measurement on the volume expired. This is the solution proposed by the embodiment of FIG. 4, which will only be described for its differences from that of Figure 1.

Le module de mesure 42 est cette fois installé dans la branche bidirectionnelle 5 du circuit patient 1 et il comporte des moyens 43 pour sélectionner le sens de l'écoulement dont le volume est à mesurer. En fonction de cette sélection, le module 42 fournit au choix une mesure de VTI ou VTE. En fonction du mode de fonctionnement du module de mesure 42, le module de commande 9 interprète comme une consigne de volume inspiré ou comme une consigne de volume expiré l'entrée appliquée en 14. Il n'y a plus de module de mesure sur la branche inspiratoire 3 ni sur la branche expiratoire 4.The measurement module 42 is this time installed in the bidirectional branch 5 of the patient circuit 1 and it comprises means 43 for selecting the direction of the flow whose volume is to be measured. Depending of this selection, the module 42 provides a choice of measurement of VTI or VTE. Depending on the mode of operation of the measurement module 42, the measurement module command 9 interprets as a volume setpoint inspired or as an expired volume setpoint the input applied in 14. There is no longer a measurement module on the inspiratory branch 3 nor on the expiratory branch 4.

Dans tous les modes de réalisation décrits, la rapidité d'exécution de l'organigramme de la figure 2 est suffisante pour que la mesure de volume effectuée à chaque cycle respiratoire permette de corriger la pression appliquée lors de la phase inspiratoire suivante. Lorsque la mesure porte sur le volume expiré, il est cependant possible que la correction de pression n'intervienne qu'en cours, et non dès le début, de la phase inspiratoire suivante.In all the embodiments described, the speed of execution of the flowchart of figure 2 is sufficient for the volume measurement to each respiratory cycle corrects the pressure applied during the inspiratory phase next. When the measurement relates to the expired volume, however, it is possible that the pressure correction intervenes only during the course, and not from the start, of the next inspiratory phase.

L'invention est applicable à tous ventilateurs capables de mesurer les volumes ou débits délivrés et de piloter automatiquement la valeur de la pression d'insufflation.The invention is applicable to all fans capable of measuring the volumes or flows delivered and automatically control the pressure value insufflation.

L'invention est applicable à tous modes de ventilation par commande de la pression, et notamment aux modes "aide inspiratoire" et "pression contrôlée". L'aide inspiratoire est un mode consistant à maintenir pendant l'insufflation une pression sensiblement constante dans le circuit patient, le patient déclenchant le début et la fin de l'insufflation par ses réflexes respiratoires. Le mode pression contrôlée est identique au mode aide inspiratoire, excepté que le patient ne déclenche pas la fin de l'insufflation, celle-ci étant déterminée par un temps fixe.The invention is applicable to all modes of ventilation by pressure control, and in particular in the "inspiratory aid" and "controlled pressure" modes. Inspiratory support is a mode of maintaining during insufflation a pressure appreciably constant in the patient circuit, the patient triggering the start and end of insufflation by its respiratory reflexes. The pressure controlled mode is identical to the inspiratory aid mode, except that the patient does not trigger the end of insufflation, this being determined by a fixed time.

Claims (14)

  1. Pressure mode breathing aid device, comprising means of detecting during operation of the device the breathing activity of a patient and of generating, as a function of that activity, inspiration and expiration phases synchronised with the said activity, means (8) for supplying during operation of the device breathable gas, during the inspiration phases, to an inspiratory branch (3) of a patient circuit (1) at an inspiratory pressure adjusted in relation to a command (AI) for the inspiratory pressure prevailing in the inspiratory branch (3) characterized by:
    means (12; 32; 42) of measuring the breathed volume (VTI, VTE),
    means of comparing the breathed volume (VTI; VTE) with a volume command (VTImini; VTEmini), and
    regulation means (11) to increase the inspiratory pressure command (AI) in the case of a breathed volume lower than the volume command (VTImini; VTEmini), and to reduce the inspiratory pressure command in the case of a breathed volume higher than the volume command (VTImini; VTEmini), so that said command (AI) is adjusted for fulfilling a flow rate condition.
  2. Device according to Claim 1, characterized in that the means (12; 32; 42) for measuring the breathed volume measure the volume amount (VTI; VTE) breathed by the patient during a breathing cycle, and the regulating means (11) are based on the result of the comparison (21) of this volume amount with the volume command in order to adjust the inspiratory pressure applied during a following cycle.
  3. Device according to Claim 1 or 2, characterized in that the means (12; 42) of measuring the breathed volume measure the volume (VTI) inspired by the patient.
  4. Device according to Claim 1 or 2, characterized in that the means (32; 42) of measuring the breathed volume measure the volume (VTE) expired by the patient.
  5. Device according to Claim 1 or 2, characterized in that the means (42) of measuring the breathed volume selectively measure the volume inspired (VTI) or the volume expired (VTE) by the patient.
  6. Device according to Claim 3, characterized in that it comprises means (8) for connecting the inspiratory branch (3) in substantially gas-tight manner with the respiratory channels of the patient during inspiratory phases of the respiratory cycle and to interrupt the flow of breathable gas in the inspiratory branch (3) during expiratory phases of the respiratory cycle, and in that the means (12) of measuring the breathed volume are connected to the inspiratory branch (3).
  7. Device according to Claim 4, characterized in that the patient circuit (1) comprises an expiratory branch (4) and in that the device comprises means (5) of connecting the expiratory branch (4) in a substantially gas-tight manner with the respiratory channels of the patient during expiratory phases of the respiratory cycle and to interrupt the flow of gas in the expiratory branch (4) during inspiratory phases of the respiratory cycle, and in that the means (32) of measuring the breathed volume are connected to expiratory branch (4).
  8. Device according to Claim 5, characterized in that the patient circuit (1) comprises a bi-directional branch (5) to which are connected the inspiratory branch (3) and an expiration path (4), in that the means (42) of measuring the breathed volume are connected to the bi-directional branch and are capable of measuring the volume in both directions of flow, means (43) being provided to select the direction of the flow in which the breathed volume measuring means (42) measure the volume.
  9. Device according to one of Claims 1 to 8, characterized in that the regulating means increase the inspiratory pressure (AI) in the said cases of a breathed volume (VTI, VTE) less than the volume command if the inspiratory pressure command (AI) is less than a predetermined maximum pressure (AImaxi).
  10. Device according to one of Claims 1 to 9, characterized in that the regulating means reduce the inspiratory pressure (AI) in the said cases of a breathed volume (VTI, VTE) higher than the volume command if the inspiratory pressure (AI) is greater than a predetermined minimum pressure (AImini).
  11. Device according to one of Claims 1 to 10, characterized in that, in at least certain of the said breathed volume (VTI; VTE) cases below and above the volume command (VTImini; VTEmini), the regulating means apply to the inspiratory pressure a pressure variation which increases with the difference between the measured breathed volume (VTI, VTE) and the volume command (VTImini, VTEmini).
  12. Device according to Claim 11, characterized in that the said pressure variation is equal in percentage to the difference between the measured breathed volume (VTI; VTE) and the volume command (VTImini; VTEmini).
  13. Device according to one of Claims 1 to 10, characterized in that, in at least certain of the said cases of breathed volume (VTI; VTE) below or above the volume command (VTImini; VTEmini), the regulating means compute a modified pressure and apply the modified pressure if the modified pressure does not go beyond a predetermined extreme value and make the inspiratory pressure equal to the predetermined extreme value if the computed modified pressure goes beyond the predetermined extreme value.
  14. Device according to Claim 9 or 13, characterized in that it comprises a means (26) of indicating the simultaneous occurrence of a breathed volume (VTI; VTE) below the volume command (VTImini) and an inspiratory pressure (AI) at least equal to a predetermined maximum pressure.
EP95930565A 1994-09-12 1995-09-11 Pressure-controlled breathing aid Revoked EP0782462B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9410839 1994-09-12
FR9410839A FR2724322A1 (en) 1994-09-12 1994-09-12 PRESSURE CONTROLLED BREATHING AID
PCT/FR1995/001158 WO1996008285A1 (en) 1994-09-12 1995-09-11 Pressure-controlled breathing aid

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EP0782462A1 EP0782462A1 (en) 1997-07-09
EP0782462B1 true EP0782462B1 (en) 1999-06-09

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EP (1) EP0782462B1 (en)
JP (1) JPH10505765A (en)
CA (1) CA2199620C (en)
DE (1) DE69510208T2 (en)
FR (1) FR2724322A1 (en)
WO (1) WO1996008285A1 (en)

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DE69510208T2 (en) 1999-11-25
EP0782462A1 (en) 1997-07-09
DE69510208D1 (en) 1999-07-15
AU3390495A (en) 1996-03-29
FR2724322B1 (en) 1997-02-07
CA2199620C (en) 2008-11-18
WO1996008285A1 (en) 1996-03-21
US5921238A (en) 1999-07-13
JPH10505765A (en) 1998-06-09
CA2199620A1 (en) 1996-03-21
AU704202B2 (en) 1999-04-15
FR2724322A1 (en) 1996-03-15

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